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The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …
Fetishizing Copies, Jessica Litman
Fetishizing Copies, Jessica Litman
Book Chapters
Our copyright laws encourage authors to create new works and communicate them to the public, because we hope that people will read the books, listen to the music, see the art, watch the films, run the software, and build and inhabit the buildings. That is the way that copyright promotes the Progress of Science. Recently, that not-very-controversial principle has collided with copyright owners’ conviction that they should be able to control, or at least collect royalties from, all uses of their works. A particularly ill-considered manifestation of this conviction is what I have decided to call copy-fetish. This is the …